This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group, ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with mild to moderate acne vulgaris.

It is anticipated that the study will be conducted at the listed Medical Centers as well as out-patient clinics at the community.

Approximately 144 male and female subjects with mild to moderate facial acne vulgaris will be enrolled in this study. Following satisfaction of the entry criteria and screening procedures, subjects will be randomized to either 5% or 10% topical foam (ARK-E021) or placebo foam. Subjects will apply the study medication once daily on the face at bedtime for 12 weeks followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patient.

Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at baseline and at weeks 3, 6, 9, 12 and 16.

Eligibility

Ages Eligible for Study:

12 Years to 40 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Main Inclusion Criteria:

Patient is male or female between the ages of 12 to 40.

A clinical diagnosis of acne vulgaris with facial involvement.

Minimum of 15 inflammatory lesions on the face (papules and/ or pustules)but not more than 40.

Participation in another investigational drug trial within 30 days prior to study entry.

Concomitant medication:

Use of systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris, systemic anti-inflammatory agents within 4 weeks prior to baseline or during the study.

Use of topical steroids, topical antibiotics, topical treatment for acne vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline or during the study.

Treatment for acne with isotretinoin or isotretinoin derivatives within 12 months prior to study entry.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494285